Pelvic Organ Prolapse (POP)Phase 4NCT07600697
Suzetrigine for Opioid-Sparing Postoperative Analgesia Following Transvaginal Pelvic Reconstructive Surgery
A Phase 4 study testing Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone) and Scheduled Acetaminophen and Ibuprofen in people with Pelvic Organ Prolapse (POP) and Stress Urinary Incontinence (SUI), run by University of California, Los Angeles at 1 site in United States.
Trial summary
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Pelvic Organ Prolapse (POP), Stress Urinary Incontinence (SUI), Postoperative Pain
- What is being tested?
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone) and Scheduled Acetaminophen and Ibuprofen
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jul 2028
- Phase
- Phase 4
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age ≥ 18 years.
- Undergoing elective transvaginal pelvic reconstructive surgery at UCLA with planned same-day discharge or 23-hour observation.
- Able to provide written informed consent.
Who cannot join
- Chronic opioid use.
- Liver failure.
- End-stage renal disease (ESRD).
- Chronic pain syndromes, including:
- Fibromyalgia Interstitial cystitis Chronic pelvic pain
- Contraindication to acetaminophen or ibuprofen.
- Use of strong CYP3A4 inhibitors within 7 days prior to surgery or anticipated need during the treatment period.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site
University of California, Los Angeles (UCLA)
Los Angeles, California, 90095
About this study
Suzetrigine is a selective NaV1.8 inhibitor that provides peripheral analgesia without opioid-related CNS effects. This single-center stepped-wedge randomized clinical trial evaluates whether a suzetrigine-based postoperative analgesic regimen provides non-inferior pain control compared with standard opioid-inclusive care following transvaginal pelvic reconstructive surgery. The study will enroll 120 participants and assess pain, opioid consumption, adverse events, and functional recovery.
Read the detailed description
Suzetrigine has demonstrated analgesic efficacy comparable to hydrocodone/acetaminophen in Phase III trials and is FDA-approved for acute pain. This trial represents the first evaluation of a NaV1.8 inhibitor in pelvic reconstructive surgery. Participants will receive either suzetrigine or standard opioid-inclusive postoperative care according to a stepped-wedge randomization schedule. Pain scores, medication use, and adverse events will be collected at 48 hours, 1 week, and 6 weeks postoperatively.
- Being tested
- Suzetrigine, Opioid Analgesics (Tramadol or Oxycodone), Scheduled Acetaminophen and Ibuprofen
- Keywords
- Suzetrigine, NaV1.8 Inhibitor, Non-opioid analgesic, pelvic reconstructive surgery, transvaginal surgery, postoperative pain, opioid-sparing analgesia, multimodal pain management, pelvic organ prolapse, randomized clinical trial, stepped-wedge design, phase 4 trial
- Medical subject headings
- Pelvic Organ Prolapse, Urinary Incontinence, Stress, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SuzetrigineDrug
Loading dose: 100 mg orally on the morning of surgery
Maintenance dose: 50 mg orally every 12 hours for 7 days
Co-administered medications: Scheduled acetaminophen and ibuprofen
Mechanism: Selective NaV1.8 sodium channel inhibitor acting on peripheral nociceptive neurons
Purpose: Opioid-sparing postoperative analgesia
Opioid Analgesics (Tramadol or Oxycodone)Drug
Tramadol: 50 mg orally every 4-6 hours as needed OR
Oxycodone: 5 mg orally every 4-6 hours as needed
Co-administered medications: Scheduled acetaminophen and ibuprofen
Purpose: Standard postoperative analgesia per institutional protocol
Scheduled Acetaminophen and IbuprofenDrug
Participants in both study arms will receive scheduled acetaminophen and ibuprofen as part of standard multimodal postoperative analgesia. These medications are administered routinely following transvaginal pelvic reconstructive surgery to reduce baseline pain, minimize opioid requirements, and support enhanced recovery.
| Study group | Role | What they receive |
|---|---|---|
| Suzetrigine-Based Regimen | Experimental | Participants receive suzetrigine as part of a multimodal postoperative analgesic regimen. Suzetrigine is administered as a loading dose on the morning of surgery followed by twice-daily dosing for 7 days, in combination with scheduled acetaminophen and ibuprofen. Receives: Drug: Suzetrigine; Drug: Scheduled Acetaminophen and Ibuprofen |
| Standard Opioid-Inclusive Analgesic Regimen | Active comparator | Participants receive standard postoperative pain management consisting of scheduled acetaminophen and ibuprofen, with opioid analgesics available as needed per routine clinical care. Receives: Drug: Opioid Analgesics (Tramadol or Oxycodone); Drug: Scheduled Acetaminophen and Ibuprofen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pain intensity (0-10 NRS) at 48 hours postoperatively
Patient-reported postoperative pain intensity measured using the 0-10 Numerical Rating Scale (NRS).
Measured: 48 hours postoperatively
Secondary outcomes (10)
Pain Intensity at 1 Week
Patient-reported pain intensity using the 0-10 NRS.
Measured: 1 week after surgery
Time to Rescue Analgesia in PACU
Time from arrival in the post-anesthesia care unit to first administration of rescue analgesic medication.
Measured: During stay in post-anesthesia care unit, measured in hours up to 23 hours
Post-Discharge Opioid Use
Total opioid consumption after discharge, measured in morphine milligram equivalents (MME).
Measured: Postoperative days 0-7
Post-Discharge Gabapentin Use
Any gabapentin or pregabalin use after discharge.
Measured: Postoperative days 0-7
Constipation
Time to first bowel movement
Additional bowel regimen use
Measured: Up to 1 week postoperatively
Nausea and Vomiting
Incidence of postoperative nausea or vomiting reported by participants.
Measured: Up to 1 week postoperatively
Dizziness or Lightheadedness
Incidence of postoperative dizziness or lightheadedness.
Measured: Up to 1 week postoperatively
Time to Return to Driving
Number of days from surgery until the participant reports resuming driving.
Measured: Up to 6 weeks
Time to Return to Work
Number of days from surgery until the participant reports returning to work.
Measured: Up to 6 weeks
Postoperative Patient-Initiated Communication Burden
Number of patient-initiated messages, calls, or portal contacts related to postoperative pain or medication concerns.
Measured: Up to 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 May 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Jul 2027 (estimated)
- Study completion1 Jul 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Pelvic Organ Prolapse (POP)Studies of the same condition, open and under way.
- More trials run by University of California, Los AngelesThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Stepped-wedge randomized design
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of California, Los Angeles
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Anne Lenore Ackerman, University of California, Los Angeles
- Investigators
- A Lenore Ackeman, MD, PhD, Principal investigator, University of California, Los Angeles
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07600697
- Sponsor's protocol ID
- 26-0498
- Status last verified
- Sep 2026
- First submitted
- 11 May 2026
- Last updated
- 15 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators do not plan to share individual participant data (IPD). Due to the sensitive nature of postoperative clinical data and institutional policies regarding patient privacy, de-identified datasets will not be made available. Study findings will be disseminated through aggregate results posted on ClinicalTrials.gov and peer-reviewed publications.
Publications
Dong S, Zhong Y, Chu L, Li H, Tong X, Wang J. Age-stratified analysis of long-term outcomes of transvaginal mesh repair for treatment of pelvic organ prolapse. Int J Gynaecol Obstet. 2016 Oct;135(1):112-6. doi: 10.1016/j.ijgo.2016.03.031. Epub 2016 Jun 20.
PubMed 27392806Jelovsek JE, Maher C, Barber MD. Pelvic organ prolapse. Lancet. 2007 Mar 24;369(9566):1027-38. doi: 10.1016/S0140-6736(07)60462-0.
PubMed 17382829Petrikovets A, Sheyn D, Sun HH, Chapman GC, Mahajan ST, Pollard RR, El-Nashar SA, Hijaz AK, Mangel J. Multimodal opioid-sparing postoperative pain regimen compared with the standard postoperative pain regimen in vaginal pelvic reconstructive surgery: a multicenter randomized controlled trial. Am J Obstet Gynecol. 2019 Nov;221(5):511.e1-511.e10. doi: 10.1016/j.ajog.2019.06.002. Epub 2019 Jun 12.
PubMed 31201808Keam SJ. Suzetrigine: First Approval. Drugs. 2025 Jun;85(6):845-851. doi: 10.1007/s40265-025-02178-w. Epub 2025 May 5.
PubMed 40323340Ali MY, Antunes FTT, Huang S, Chen L, Zamponi GW. Pharmacological inhibition of NaV1.8 by suzetrigine reveals potent analgesic potential without tolerance development in mice. Mol Brain. 2025 Nov 13;18(1):86. doi: 10.1186/s13041-025-01253-3.
PubMed 41233910Stewart RG, Osorno T, Fujita A, Jo S, Ferraiuolo A, Carlin K, Bean BP. Modulation of human dorsal root ganglion neuron firing by the Nav1.8 inhibitor suzetrigine. Proc Natl Acad Sci U S A. 2025 Jun 3;122(22):e2503570122. doi: 10.1073/pnas.2503570122. Epub 2025 May 27.
PubMed 40424150